Chemical Renal Ethanol Sympatholysis Under CT Guidance Use for the Control of Therapy-Resistant Hypertension
NCT ID: NCT02653222
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2016-02-29
2018-02-28
Brief Summary
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To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.
The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Renal sympathicolysis
The patient will have:
1. Ambulatory Blood Pressure Monitoring
2. Magnetic Resonance Angiography
3. Blood test
4. Renal sympathicolysis
5. Ambulatory Blood Pressure Monitoring
6. Magnetic Resonance Angiography
Renal sympathicolysis
Ambulatory Blood Pressure Monitoring
1 month before and after surgery the patient will have an ABPM over 24h
Magnetic Resonance Angiography
1 month before and after surgery the patient will have a MRA
Blood test
complete blood count, blood platelets, coagulation profile, irregular agglutinins search
Interventions
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Renal sympathicolysis
Ambulatory Blood Pressure Monitoring
1 month before and after surgery the patient will have an ABPM over 24h
Magnetic Resonance Angiography
1 month before and after surgery the patient will have a MRA
Blood test
complete blood count, blood platelets, coagulation profile, irregular agglutinins search
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient with triple antihypertensive therapy (maximum tolerated dose) with a diuretic, except for anuric patients, and without modification treatment:
* in the last two months,
* expected in the next three months,
* renal transplanted patients with native kidneys followed for hypertension before transplant, and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation OR
* chronic renal failure patient with dialysis and having a arterial systolic pressure ≥ 160 mmHg on the average of 3 measurements taken during the screening consultation and during at least one previous consultation
* patient affiliated to social security or similarly regime
* patient who signed the consent to participate in the study
* renal artery anatomy against-indicating the procedure including:
* 3 homolateral renal arteries
* kidney surgery including bypass surgery or renal artery reimplantation
* volume-dependent type of hypertension
* secondary hypertension (not included nephropathy)
* orthostatic hypotension associated with symptoms during the previous year
* medical history including:
* acute coronary syndrome, unstable angina, stroke within 6 months preceding the period of inclusion,
* surgery scheduled on the kidney, the renal arteries or the retroperitoneum during patient participation in the study period
* chronic alcoholism
* anticoagulants or antiplatelet agents for which a therapeutic window can not be considered (except aspirin dose less than or equal to 160mg / day)
* contraindication to the realization of an MRI
* included in another trial assessing a medicament or a medical device or a surgical procedure
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Julien Ghelfi, Md
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital
Grenoble, Isère, France
Grenoble Association for the Dialysis of Uremic Chronicles
La Tronche, Isère, France
Countries
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Other Identifiers
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2015-002579-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
38RC15.182
Identifier Type: -
Identifier Source: org_study_id
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